Kornimate/medical-research-clean huggingface dataset:
ernährungs-interventions-fettleber-studie (interventional study on nutritional effects on nafld)

Conditions: NAFLD; Obesity; Prediabetes; Dyslipoproteinemia

Summary: epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (pufa) rather than mono-unsatured fatty acids (mufa) are associated with lower hepatic lipid content (hcl) and may facilitate a decrease of hcl in case of non-alcoholic fatty liver disease (nafld). the investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased hcl, fulfilling criteria for nafld. the study will compare two dietary interventions in parallel design, one containing mainly pufa (canola oil), one containing only mufa (olive oil). the intervention of 8 weeks is accomodated by dietary counseling. metabolic outcome variables will be assessed with mr spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).

epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (pufa) rather than mono-unsatured fatty acids (mufa) are associated with lower hepatic lipid content (hcl) and may facilitate a decrease of hcl in case of non-alcoholic fatty liver disease (nafld). a typical source for pufas are fish and certain plant oils, a source of almost pure mufas is olive oil. the investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased hcl, fulfilling criteria for nafld. the investigation focusses on male participants to avoid sex-related differences in the results. the study will compare two isocaloric dietary interventions in parallel design, one containing mainly pufa (canola oil), one containing only mufa (olive oil). the intervention of 8 weeks is accomodated by dietary counseling (4 sessions). metabolic outcome variables will be assessed with mr spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).

Eligibility criteria:
inclusion criteria: * increased hepatic fat content (nafld) * bmi between 30 and 35 kg/m² exclusion criteria: * diabetes * severe cardiac, pulmonary or gastrointestinal disorders * hepatic disorders other than nafld * alcoholism * medication with metabolic side or main effects (e.g. statins)
urdu version of profitmap-neck questionnaire in population with chronic neck pain a reliability and validity study

Conditions: Chronic Neck Pain

Summary: the aim of this study is to translate or culturally adapt profitmap-neck into urdu language and to investigate the reliability and validity of the profitmap-neck in pakistani population having chronic neck pain. also check it's correlation with neck disability index.

as with prior suggestions, the english version of the profitmap-neck will be translated and culturally modified.in population having chronic neck pain profitmap-neck will be distributed among one hundred and thirty six participants selected by a convenience sampling technique based on pre-defined inclusion and exclusion criteria.the questionnaire will be filled out by two observers on the same day to examine inter and intra-observer reliability of the final profitmap-neck and neck disability index. for the inter-observer evaluation, there will be a 2 hour delay between the first and second application. after 7 days, observer-1 will conduct a third assessment (re-testing) for intra-observer evaluation.the statistical package of social sciences program will be used to examine the data.

Eligibility criteria:
inclusion criteria non-specific chronic neck pain age 18-65 years neck pain that isn't caused by a traumatic event exclusion criteria neck pain due to any type of surgery neck pain as a result of an injury neck pain due to broken bone or dislocation rheumatological issues pregnant women any cardiovascular disorders any neurological problems cord compression insufficiency of the vertebrobasilar artery

Keywords: urdu version of profitmap-neck non-specific chronic neck pain psychometric properties validity functional limitations reliability
the effects of physiologic oxygen tension on clinical in vitro fertilization outcomes

Conditions: Pregnancy; Infertility

Summary: primary aim * evaluate whether human embryo exposure to physiologic levels of oxygen during culture improves the percentage of women who deliver a baby following in vitro fertilization and embryo transfer. hypothesis to be tested: physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical in vitro fertilization embryo transfer (ivf-et). secondary aims evaluate whether human embryo exposure to physiologic levels of oxygen during culture during in vitro fertilization and embryo transfer * improves embryo cleavage * improves clinical pregnancy rate * reduces multiple pregnancy rate * reduces miscarriage rate hypothesis to be tested: physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical pregnancy rates and reduces miscarriage rates in clinical ivf-et.

study design this will be a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (soc, 20%) oxygen tension with 840 eligible couples recruited to participate. the randomization scheme will be coordinated through the central data coordinating center (dcc-yale) and the randomization will be stratified by age group of the woman (18-34, 35-37, 38-40 and 40-42) and each participating site. treatment couples will be randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.

Eligibility criteria:
inclusion criteria: the critical inclusion criteria will be the diagnosis of infertility and the need for in vitro fertilization as determined by the treating clinician. (we do not plan to alter the standard of care for the indication for ivf at any of the sites.) * couple's age must be between 18 and 42 years old * patient and partner are scheduled to undergo in vitro fertilization for treatment of infertility * couple able to participate in a research project and a) able to understand study requirements b) willing to sign informed consent c) able to return for required follow-up d) have access to telephone exclusion criteria: critical exclusion criteria for this trial will be medical conditions which may complicate treatment or no plans to undergo embryo transfer, as in patients banking embryos prior to cancer therapy. in addition, donor egg and frozen embryo transfer cycles will be excluded. * medical contraindication to egg retrieval or pregnancy * inability to participate in a research project (non-english speaking or unable to read or write and/or concurrent participation in any other interventional trial) * couple with more than three previous failed ivf cycles * donor egg and frozen embryo transfer cycles

Keywords: pregnancy infertility physiologic oxygen tension atmospheric oxygen tension
azd6765 for treatment resistant depression

Conditions: Depression

Summary: the purpose of this study is to determine whether treatment with azd6765 will have an antidepressant effect with patients who have treatment resistant depression.


Eligibility criteria:
inclusion criteria: * diagnosis of depression * inadequate response to an adequate course of antidepressants exclusion criteria: * psychiatric disorder other than depression * pregnancy or lactation * current diagnosis of cancer

Keywords: long-term depression
dementia care challenges among a sample of informal caregivers in egypt

Conditions: Dementia

Summary: dementia is a widespread incapacitating mental syndrome that carries a significant challenge for healthcare systems, persons with dementia, and their caregivers. the world health organization estimates that there is "more than 55 million persons live with dementia worldwide, and there are nearly 10 million new cases every year" in egypt there are many studies had investigated caregiver burden with chronic ill elderly as physical or psychiatric diseases; however, studies focusing on caregiving patients with dementia (pwd), especially the psychological aspect, has been raised just few years ago. some focused on psychiatric comorbidities of care givers, others correlated caregivers' quality of life with dementia staging. other research groups designed educational programs and psychosocial interventions for training informal caregivers with significant psychological burden reduction at the end of the studies , also another group focused their study on the negative emotions expressed by caregiver towards pwd. still there are many aspects of caregiving not explored considering the financial burden, lack of formal educational resources, stigma, cultural and religious values related to caregiving.

our study aims: 1. to assess challenges of dementia-related knowledge among a sample of dementia informal caregivers 2. to assess the needs of persons with dementia and their informal caregivers 3. to assess the burden of caregiving among a sample of dementia informal caregivers 4. to assess possible culturally related challenges of caregiving among a sample of dementia informal caregivers the study will be carried out through face-to-face interview, telephone interview, and online survey from community sources, including support groups in social media, memory clinics, outpatient clinics (geriatric medicine, neurology, or psychiatry), and social support groups of non-governmental organizations.

Eligibility criteria:
inclusion criteria: * informal caregivers aged 18 years or older * informal caregiver in daily contact for care with the person with dementia for at least one year. exclusion criteria: * informal caregivers who are unable or unwilling to communicate. * formal caregivers
adolescent cancer telemedicine for pain management

Conditions: Cancer

Summary: pain in adolescents undergoing treatment for cancer is a common problem, often related to treatment or to the cancer itself. due to increasing outpatient-based cancer treatment, the burden of care and pain management has shifted to the home environment. yet, there are limited interventions that target the management of pain at home. adolescence is marked by increased need for independence and social integration, both of which can be impaired by pain or fear of pain. to address unique needs during this developmental period, this study will test a telemedicine program to enhance pain knowledge and pain control strategies in adolescents ages 12-21 years who are undergoing treatment for cancer. fifty-six teens will be randomized to an intervention or wait-list control condition. patients randomized to the waitlist control condition will receive the intervention following completion of the waitlist condition. the intervention will consist of four weekly 30-45 minute telemedicine (online via videoconferencing platform) sessions with a trained social work or psychology provider. sessions will focus on pain psychoeducation, coping tools, communication, and stress management. participants will complete online questionnaires assessing pain coping, pain management, and pain-related impairment at pre-intervention, post-intervention, and 1- and 2-month follow-up.


Eligibility criteria:
inclusion criteria: 1. age 12-21 years 2. at least two months post cancer diagnosis 3. experienced pain in the past month as defined by at least one pain experience rated \>3 on a 0-10 numeric rating scale 4. access to the internet for intervention sessions 5. fluent in english (given that the intervention will be delivered in english, all adolescents will need to be fluent in english to participate.) exclusion criteria: 1. significant cognitive impairment that may affect their ability to participate
phase 2 study of aln-rsv01 in lung transplant patients infected with respiratory syncytial virus (rsv)

Conditions: Respiratory Syncytial Virus Infections

Summary: to evaluate the safety,tolerability and antiviral activitity of aln-rsv01 in rsv infected lung transplant patients


Eligibility criteria:
inclusion criteria: * single or bilateral lung transplant recipients * confirmed rsv infection * greater than 90 days post current lung transplant * rejection free for a minimum of 1 month exclusion criteria: * antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis * bronchiolitis obliterans syndrome (bos) grade 3 or any state bos with fev1 that has not been stable for at least 3 months * use of alemtuzumab within 9 months prior to screening; anti-thymocyte globulin(atg) or thymoglobulin within 3 months of screening: concurrent use of \>= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy * active treament for acute graft rejection

Keywords: aln-rsv01 respiratory syncytial virus
a trial investigating the pain-relieving properties of lu ag06474 in healthy adult participants

Conditions: Healthy Participants

Summary: the main goal of this trial is to learn about the effect of lu ag06474 on a battery of evoked pain tests when a single dose is given to healthy adult participants. the effects of lu ag06474 will be compared with 2 approved pain-relieving medications (ibuprofen and pregabalin) and with a placebo (a treatment that looks like the trial treatment but does not have any medicine in it). each participant will receive 1 dose of each of these treatments during the trial (lu ag06474, ibuprofen, pregabalin, and placebo), with 1 week between treatments. all treatments will be taken orally (by mouth), either as a liquid or a capsule.


Eligibility criteria:
inclusion criteria: * the participant has a body mass index (bmi) ≥18.5 and ≤32 kilograms per meter squared (kg/m\^2) at the screening visit and at the trial baseline visit. * the participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an ecg, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. exclusion criteria: * the participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff. * the participant has fitzpatrick skin type iv, v and vi, wide-spread acne, tattoos, or scarring interfering with the area of interest (that is, upper back). * the participant is currently enrolled in another clinical trial or used any investigational drug or device within 3 months (or \<5 half-lives of that product, whichever is longer) prior to dose of investigational medicinal product (imp), or has participated in more than 4 investigational drug studies within 1 year prior to screening. * the participant takes any disallowed medication within 14 days from first dose of trial drug. * the participant has been vaccinated ≤14 days prior to the first dose of imp. * the participant is pregnant, breastfeeding, intends to become pregnant, or is of child bearing potential and not willing to use adequate contraceptive methods.
effects of delayed muscle pain on respiratory muscle function

Conditions: Muscle Soreness; Exercise; Respiratory Muscles; Respiratory Function Tests

Summary: the aim of the study was to determine whether delayed-onset muscle soreness (doms) in trunk muscles has an effect on respiratory function parameters, respiratory muscle strength, respiratory muscle endurance, and exercise capacity.

in 24 healthy university students was induced for the trunk muscles with a load equals to 80% of the maximum repetitive voluntary contraction. pulmonary function parameters, respiratory muscle strength and endurance, exercise capacity, pain, fatigue, and dyspnea perception severity were recorded before doms and at the 24th and 48th hours after doms. after doms, there is a decrease in respiratory performance values and exercise capacity of healthy individuals and athletes. therefore, it should be taken into account that delayed muscle soreness before the competition may affect performance. it may be beneficial to take precautions for delayed muscle pain while creating training and exercise programs, and to create treatment programs in case of the emergence of doms.

Eligibility criteria:
inclusion criteria: * being a healthy individual between the ages of 18-25 * not having a regular exercise habit * no infection until at least 3 weeks before the study exclusion criteria: * lung disease * cardiovascular disease * neurological disease * orthopedic disease

Keywords: muscle soreness exercise respiratory muscles respiratory function tests
a window of opportunity study to investigate mechanisms of actions of novel therapeutic agents in patients with resectable solid tumor malignancies

Conditions: Solid Tumor

Summary: this is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a master protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies. each sub-protocol conducted under the master protocol will evaluate different novel therapeutic agent(s). estimated enrollment is 15 subjects per sub-protocol.

patients will have a short-course (4-weeks) administration of a given compound in the timeframe between the diagnostic biopsy and the surgical resection. a pre-treatment tumor biopsy will be obtained, and blood samples will be collected before, during, and at the end of treatment.

Eligibility criteria:
inclusion criteria: 1. must have biopsy-proven solid tumor that is eligible for elective surgical resection, disease does not require immediate therapy, and there is no approved/ standard therapy available that is shown to prolong overall survival. 2. ecog performance status of 0 or 1. 3. must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy. 4. willing to provide tissue and blood samples for research. exclusion criteria: 1. the following solid tumors are not eligible: primary brain tumor, ocular melanoma, head and neck cancer, breast cancer, prostate cancer, testicular cancer, and stage iii rectal cancer. 2. any active malignancy within 3 years prior, except: adequately treated basal cell or squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1) treated with curative intent. 3. any uncontrolled intercurrent illness, including but not limited to: symptomatic congestive heart failure, unstable angina pectoris or coronary angioplasty or stenting within 6 months prior to enrollment, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements, or ongoing or active infection. 4. any known sensitivity to or history of allergic reaction to compounds of similar chemical or biological composition of study drug(s). 5. unwilling or unable to follow the study schedule. other protocol defined inclusion/exclusion criteria may apply.
prospective pilot study of multi-actor tolerance evaluation using the virare device (virtual reality assisted rehabilitation) in visually impaired patients

Conditions: Visual Impairment

Summary: our study aims to validate the relevance of a virtual reality tool (virare: virtual reality assisted rehabilitation) in the assessment and rehabilitation of visually impaired subjects.


Eligibility criteria:
inclusion criteria: * the patient signed the consent form * the patient is affiliated to a health insurance programme * the patient presents ophthalmological or neurological pathologies with impact on visual function (retinopathy pigmentosa, macular dystrophy, glaucoma, age-related macular degeneration, cerebrovascular accident ...). * the patient is visually impaired (visual acuity less than 3/10 of both eyes or concentric narrowing of the goldmann binocular visual field or homonymous hemianopia) of category i, ii, iii or iv of the who classification. exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by another study * the patient is under safeguard of justice. * the patient is under judicial protection. * it is not possible to give the patient (or his/her trusted-person) informed information. * the patient is pregnant or breastfeeding. * the patient has a sensory or cognitive disability with a given scale (mms \< 24) * the patient has difficulty moving including major locomotor difficulties.
mri-guided bone marrow biopsies of prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of this study is to target lesions of the prostate in the bone and to biopsy these lesions using mri to identify the areas.

* this study involves a one-time, mri-guided bone marrow biopsy. prior to this procedure, patients will need to have a bone scan performed within the last three months and a psa blood test drawn within one month of registration to the study. * patients are also required to participate in the dfci research study "collection of specimens and clinical data for patients with prostate cancer or at high risk for prostate cancer".

Eligibility criteria:
inclusion criteria: * histologic diagnosis of prostate cancer * bone scan consistent with or suspicious of metastatic prostate cancer within last three months * platelet count \> 50,000/ul * pt and aptt \< 1.5 x control * at least one week removed from taking aspirin or coumadin * currently participating in protocol "collection of specimens and clinical data for patients with prostate cancer or at high risk for prostate cancer" exclusion criteria: * devices incompatible to mr studies (e.g. pacemakers, ear implants, etc.)

Keywords: mri-guided bone marrow biopsy
iris-firehawk® cohort in the iris-des registry

Conditions: Coronary Stenosis; Coronary Disease

Summary: the objective of this study is to evaluate effectiveness and safety of firehawk® stent in the "real world" daily practice as compared with other drug-eluting stents.


Eligibility criteria:
inclusion criteria: * age 19 and more * patient with firehawk® coronary stent exclusion criteria: * intervention with firehawk® coronary stent and other drug eluting stent at the same time * life-expectancy less than 1 year * cardiac shock

Keywords: firehawk coronary artery disease drug eluting stent
study of lx3305 and methotrexate in subjects with stable rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to evaluate the effect of lx3305 on methotrexate (mtx) pharmacokinetics and to evaluate the safety and tolerability of lx3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of mtx.


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years old * must be willing to practice 2 adequate methods of contraception for the duration of the study * rheumatoid arthritis present for at least 3 months; functional class i, ii, or iii as defined by acr criteria * treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study * ability to provide written informed consent exclusion criteria: * women who are pregnant or nursing * history of other current inflammatory arthritis * history of opportunistic infection * history of recurrent infections or current infection 2 weeks prior to start of study * presence of significant, uncontrolled medical problems * treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study * use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, h-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start * receipt of live vaccine within 8 weeks prior to study start * rheumatoid arthritis, functional class iv as defined by acr criteria